Primary Device ID | 00854150007088 |
NIH Device Record Key | 40969518-44a1-4afe-9cf5-5b454b4b0c91 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SF-3XXL Solofit AAMI III SMS Gown XX-Large |
Version Model Number | SF-3XXL |
Catalog Number | SF-3XXL |
Company DUNS | 080246656 |
Company Name | OPERATING ROOM INNOVATIONS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com | |
Phone | 716-681-0866 |
rdean@exactmm.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00854150007071 [Primary] |
GS1 | 00854150007088 [Package] Contains: 00854150007071 Package: Case [28 Units] In Commercial Distribution |
FYA | Gown, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-10-23 |
Device Publish Date | 2017-03-02 |
26975424191642 - Operating Room Innovations, Inc | 2023-04-13 Shield Guards-Removable Peel Away, 2 per Pouch |
16975085709401 - ORI | 2023-04-12 HaloFit Large with Face Shield AAMI IV |
16975085709418 - ORI | 2023-04-12 HaloFit XXX-Large with Face Shield AAMI IV |
26975424191451 - ORI | 2023-04-12 Face Shield, Attached with Full Head Covering |
26975424191468 - ORI | 2023-04-12 ORI Drop Stop |
26975424191475 - ORI | 2023-04-12 Face Shield, Attached w. AAMI IV Head Covering |
26975085708333 - ORI | 2023-04-11 SmokeStop - Smoke Evacuation 20" Tubing |
26975085708524 - ORI | 2023-04-11 SterileBack Toga XL-EL w. Face Shield |